Qualification, process validation and cleaning validation

  • 2° EDITION: 12 June 2024
  • Online
  • Italian

Training overview

Since October 2015, Annex 15 of the European GMP has been in effect. With this revision, modern process aspects are also under discussion; there are some significant changes and many similarities to the FDA guideline on Process Validation.

The course “Qualification, process validation and cleaning validation” will cover the highlights of the new document and compare EU and FDA approaches.

The EMA guideline on “Dedicated Facilities and Exposure Limits for Cleaning Validation” and Annex 15 now address the Permitted Daily Exposure (PDE) approach: the course will explain the impact of these documents on Cleaning Validation.

Key points of the training

  • Address qualification and validation activities with a more modern, practical and scientific vision and approach
  • Understand the similarities and differences between Annex 15 and the FDA Process Validation Guidance
  • Understand how to apply the concepts of Statistical Process Control and PDE
  • Compare with colleagues and the lecturer to share experiences, examples, and business case studies

PROGRAM

09:00 – 13:00 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION

  • Regulatory references and the principles of Validation
  • The Annex 15 EU GMP
  • The FDA guideline on process validation and Annex 15: similarities and differences between US and EU expectations
  • Validation Master Plan and documentation of qualification and validation
  • Application of the concepts of Risk Assessment, Design of Experiments and Statistical Process Control
  • Revalidation versus Continued Process Verification and Ongoing Process Verification
  • Case studies: statistical evaluation of validation data and application of statistical tools in Continued Process Verification
  • Cleaning Validation: regulatory references and introduction of relevant guidelines
  • Key concepts, risk management, cleaning validation plan
  • Documentation
  • Revalidation and verification
  • Analytical method validation, sampling methods
  • Definition of limits: new approach
  • Development of a Cleaning Validation plan (worst case rating of products, grouping and matrixing, validation of cleaning procedure, Levels of acceptance and examination of the “worstcase”)
  • Innovative aspects and concepts

Quality Assurance, Validation team, Production, Quality Control, Engineering.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.

Speakers

Angela Petrigliano

Angela Petrigliano

Operations Manager Process & Quality

Graduated in 1992 in Pharmaceutical Chemistry and Technology at the University of Siena, she has 30 years of professional experience in pharmaceutical companies and in the world of pharmaceutical consultancy. She began her career in 1992 in the Research and Development of the Technobiochip. Subsequently she worked in Quality Assurance at A. Menarini Industrie Farmaceutiche Riunite (Florence) and in the Corporate Quality Department of the Menarini Group from 1996 to 2000 where she gained experience in the different sectors of Quality Assurance and in Operations. From 2000 to 2009 she worked at Bayer Biologicals (Rosia – SI) where she assumed roles of increasing responsibility up to Plant Manager and Head of Operations. From 2009 to 2011 she was Qualified Person and Plant Manager at Galenica Senese. Since 2012 she has been Operations Manager Process & Quality at Pharma D&S; she is also involved in training activities within Pharma Education Center.

Register now

Early Bird 10%
Within 2 months before the start of the training
720€
800€
Early Bird 5%
Within 1 month before the start of the training
760€
800€
Full price

800€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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